A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

Trial Title: A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

NCT ID: NCT06461156

Condition: Locally Advanced or Metastatic NSCLC

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
locally advanced or metastatic NSCLC
EGFR C797S
HS-10504

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HS-10504
Description: HS-10504 will be administered orally once daily in a continuous regimen. Participants will continue treatment until experiencing objective disease progression or meeting other protocol-specified criteria for discontinuation of study treatment.
Arm group label: HS-10504

Summary: HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Males or females, aged ≥ 18 years. - Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC - Progressive disease on or after prior treatment with EGFR-TKIs. - Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing. - At least 1 target lesion according to RECIST 1.1. - ECOG PS score: 0-1. - Estimated life expectancy> 12 weeks. - Men or women should be using adequate contraceptive measures throughout the study. - Women must have the evidence of non-childbearing potential. - Signed and dated Informed Consent Form. Exclusion Criteria: - Subjects with known oncogenic driver genes other than EGFR. - Subjects with mixed cell histologic or with phenotypic transformation. - Treatment with any of the following: 1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors. 2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study. 3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose 4. Uncontrolled pleural effusion or ascites or pericardial effusion. 5. Major surgery within 4 weeks before the first dose. 6. CNS metastases with symptomatic or active progression. - Subjects who have any grade ≥2 residual toxicities from prior therapies. - Subjects who have history of other primary malignancies. - Inadequate bone marrow reserve or hepatic and renal functions. - Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction. - Hypersensitivity to any ingredient of HS-10504. - Moderate to severe pulmonary diseases. - Prior history of significant neurological or mental disorders. - Women who are breastfeeding or pregnant or planned to be pregnant during the study period. - Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator. - Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 30, 2024

Completion date: March 31, 2027

Lead sponsor:
Agency: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06461156